CE marking for Jena Valve TAVI system for aortic stenosis

Replacement of the aortic valve remains an effective treatment for severe aortic stenosis (AS). Although open surgical aortic valve replacement has been the gold standard treatment for severe AS, many patients do not have this option due to severe co-morbidities. Catheter-based aortic valve implantation has shown promising results in providing treatment options for patients with severe AS. For cardiac surgeons to be involved and to play an important role in the care of these patients, comfort with this methodology is imperative.

JenaValve, a German developer of transcatheter delivered aortic valve systems, has received CE marking for its transapical trans-aortic valve implantation (TAVI) system. It comprises of catheter delivery system and the prosthetic heart valve. It also includes a porcine root valve and a Nitinol stent designed to improve hemodynamic performance and durability. The prosthesis comes in three sizes and covers aortic annulus diameters of 21-27mm. CE marking was awarded following successful outcomes from a pivotal multi-center German study of 73 patients with severe symptomatic aortic valve stenosis.

The system is to be used for the...

treatment of aortic stenosis in older, high-risk patients who are ineligible for open heart surgery. The primary endpoint of the trial was the 30-day mortality rate. The secondary endpoints were the rate of successful implantation, as well as further parameters for performance and safety of the prosthetic heart valve.

The integrated positioning feelers provide easy and accurate placement of the prosthesis. While the unique JenaClip™ mechanism provides additional anchoring support to prevent migration of the valve.

Two catheter-based delivery systems are available so that the prosthesis can be placed at the aortic annulus retrograde in a transfemoral approach, or antegrade in a transapical approach. Both systems provide easy maneuverability, positioning and repositioning capabilities.

TAVI has gained momentum this year with Edward’s is the fist valve approved by FDA. Other medical device giants, Medtronic, Boston Scientific and St. Jude Medical are at various stages in development of TAV valve.